Weekly Bendamustine and Bortezomib Combination Therapy in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or B-CLL: A Single-Center Phase 2 Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Peter Moosmann
- Enrollment
- 12
- Primary Endpoint
- Optimal Bendamustine Dosage for Further Studies
Study Overview
Brief Summary
The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable.
Detailed Description
Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population.
Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptomatic recurrent or refractory indolent NHL or B-CLL
- •Adequate organ and bone marrow function
- •Karnofsky greater than 50%
Exclusion Criteria
- •Candidates for autologous stem cell transplantation
- •Secondary high grade lymphoma
- •Concurrent severe medical condition
Arms & Interventions
Bendamustine and Bortezomib
Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section
Intervention: Bendamustine (Drug)
Bendamustine and Bortezomib
Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section
Intervention: Bortezomib (Drug)
Outcomes
Primary Outcomes
Optimal Bendamustine Dosage for Further Studies
Time Frame: Three weeks after treatment termination
Secondary Outcomes
No secondary outcomes reported
Investigators
Peter Moosmann
MD PhD
Kantonsspital Aarau